Last updated: 11/03/2018 21:42:49

Bioequivalence study of Raperazole 20mg DR tabs and PARIET® 20 mg DR tabs under fed conditions

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GSK study ID
201528
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Clinicaltrials.gov ID
NCT02605395
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Rabeprazole from Raperazole 20mg DR tabs (GSK, Egypt) and PARIET 20 mg DR tabs (JANSSEN, EGYPT) after a single oral dose administration of each to healthy adults under fed conditions
Trial description: This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.
In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
PARIET is a registered trademark of EISAI Co. Limited.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Maximal measured plasma concentration (Cmax) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC [0-t]) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Mean area under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity]) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Secondary outcomes:

Mean time to the maximum plasma concentration (tmax) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Mean apparent first-order elimination or terminal rate constant (Ke) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Mean terminal half life (t1/2) of Rabeprazole

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Interventions:
  • Drug: IDIAZOLE 20mg DR tabs
  • Drug: PARIET 20 mg DR tabs
    • Enrollment:
    70
    Primary completion date:
    2014-30-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Gastrointestinal Diseases
    Product
    rabeprazole
    Collaborators
    Not applicable
    Study date(s)
    March 2014 to March 2014
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy male or female, age 18 to 55 years, inclusive.
    • Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
    • Subjects with known allergy to the products tested.
    • Subjects whose values of BMI were outside the accepted normal ranges.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female, age 18 to 55 years, inclusive.
    • Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
    • Medical demographics without evidence of clinically significant deviation from normal medical condition.
    • Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
    • Subject does not have allergy to the drugs under investigation.
    Exclusion criteria:
    • Subjects with known allergy to the products tested.
    • Subjects whose values of BMI were outside the accepted normal ranges.
    • Female subjects who were pregnant, nursing or taking birth control pills.
    • Medical demographics with evidence of clinically significant deviation from normal medical condition.
    • Results of laboratory tests which are clinically significant.
    • Acute infection within one week preceding first study drug administration.
    • History of drug or alcohol abuse.
    • Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
    • Subject is on a special diet (for example subject is vegetarian).
    • Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
    • Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
    • Subject has a history of severe diseases which have direct impact on the study.
    • Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
    • Subject intends to be hospitalized within 6 weeks after first study drug administration.
    • Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 ml in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cairo, Egypt
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-30-03
    Actual study completion date
    2014-30-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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